Department of Medical Informatics, College of Medicine, The Catholic University of Korea, Seoul, Korea.
Department of Endocrinology and Metabolism, College of Medicine, The Catholic University of Korea, Seoul, Korea.
J Korean Med Sci. 2019 Jan 16;34(4):e28. doi: 10.3346/jkms.2019.34.e28. eCollection 2019 Jan 28.
Clinical studies can be conducted to gather real world evidence (RWE) not available from randomized controlled trials, providing new information and knowledge. Although the concept of RWE emerged relatively recently, numerous clinical studies are utilizing it. However, many researchers are engaging in trial and error that may not overcome the various biases that occur in electronic medical record (EMR)-based RWE studies. While RWE can reflect the real world, there are still limitations to its acceptance. There are many hurdles in using RWE and solutions must be explored. Results based on RWE may be overestimated and it can be difficult to derive good quality results. This paper discusses data quality management, direct chart review, sample size, study design, and the interpretation of EMR-based RWE. More specifically, this paper shares the experience of the various hurdles that occur when conducting RWE studies and discusses the easy-to-false errors. RWE is still in the developmental stage and numerous aspects of RWE use remain unclear. Nonetheless, despite its many limitations, increasing use of RWE is still anticipated. This will require continued experience and effort in using RWE, as well as upgrading RWE research through the accumulation of information on such experiences and efforts.
临床研究可以用来收集随机对照试验中无法获得的真实世界证据（RWE），从而提供新的信息和知识。尽管 RWE 的概念是最近才出现的，但许多临床研究都在使用它。然而，许多研究人员都在进行试错，这可能无法克服电子病历（EMR）中 RWE 研究中存在的各种偏倚。虽然 RWE 可以反映现实世界，但它的接受程度仍然存在局限性。在使用 RWE 方面存在许多障碍，必须探索解决方案。基于 RWE 的结果可能会被高估，并且很难得出高质量的结果。本文讨论了数据质量管理、直接图表审查、样本量、研究设计以及基于 EMR 的 RWE 的解释。更具体地说，本文分享了在进行 RWE 研究时遇到的各种障碍的经验，并讨论了容易出现的错误。RWE 仍处于发展阶段，RWE 使用的许多方面仍不清楚。尽管存在许多局限性，但预计 RWE 的使用仍将增加。这将需要在使用 RWE 方面不断积累经验和努力，以及通过积累有关这些经验和努力的信息来提升 RWE 研究。
